Bard Ivc Filters Prods. Liab. Litig. v. C. R. Bard, Inc. (In re Re)
| Decision Date | 07 September 2018 |
| Docket Number | No. MDL 15-02641-PHX-DGC,No. CV-16-00893-PHX-DGC,MDL 15-02641-PHX-DGC,CV-16-00893-PHX-DGC |
| Parties | IN RE: Bard IVC Filters Products Liability Litigation, Lisa Hyde and Mark E. Hyde, a married couple, Plaintiffs, v. C. R. Bard, Inc., a New Jersey corporation; and Bard Peripheral Vascular, Inc., an Arizona corporation, Defendants. |
| Court | U.S. District Court — District of Arizona |
The case brought by Plaintiffs Lisa and Mark Hyde is set for a bellwether trial later this month. The parties have filed motions in limine ("MILs") in advance of trial. The Court previously ruled on Plaintiffs' MILs 4 and 5. Doc. 12507. This order will rule on the remaining MILs except Defendants' MIL 5.1
Plaintiff Lisa Hyde received a Bard IVC filter implant in 2011. In 2014, she learned that the filter had tilted, perforated the IVC wall, and fractured. The filter and fractured limbs were removed three months later.2
Mrs. Hyde and her husband assert various claims. Doc. 364; Doc. 1, Case No. CV-16-00893. Applying Wisconsin law, the Court granted summary judgment to Defendants on several claims. Doc. 12007. Plaintiffs continue to assert claims for strict liability design defect (Count III), negligent design (Count IV), negligence per se (Count IX), loss of consortium (Count XV), and punitive damages. Id. at 19.
In the Booker case, the Court denied a motion in limine to exclude evidence of the FDA's 510(k) clearance process and lack of enforcement action against Bard. Doc. 9881. Plaintiffs state that they are neither re-urging nor seeking reconsideration of that order, but instead seek to exclude evidence beyond the scope of the order. Doc. 12095 at 1 n.1. Plaintiffs assert that the FDA evidence admitted in the Booker and Jones bellwether trials created an impression that the FDA made safety and efficacy determinations by implying that Bard "worked hand-in-hand with the FDA" and "conducted a design process with the FDA." Id. at 2. Plaintiffs seek to exclude evidence regarding (1) Bard's post-market surveillance communications with the FDA, (2) the FDA's reclassification of IVC filters from class III to class II devices, and (3) "gratuitously offered" testimony about FDA communications unrelated to the 510(k) process. Id. at 2-4.
Bard's post-market surveillance communications with the FDA are relevant to the question of whether Bard acted reasonably for purposes of the negligent design claim, particularly since Plaintiffs claim that the G2 line of filters constituted an ongoing design and iteration of the original G2 filter. See Stevens v. Stryker Corp., No. 12-CV-63-BBC,2013 WL 4758948, at *4 (W.D. Wis. Sept. 4, 2013) (). Post-market communications are also relevant to Plaintiff's punitive damages claim that Bard acted maliciously and with intentional disregard for the rights of others. See Wis. Stat. § 895.043(3) (). Additionally, Plaintiffs have stated that their punitive damages case will be based in part on Bard's failure to take post-sale remedial actions. See Doc. 12400 at 17-19. Bard's post-market surveillance of its products, and its and communications with the FDEA about that surveillance, are directly relevant to this issue. Finally, evidence regarding Bard's post-market communications with the FDA and the agency's lack of enforcement action with respect to Bard filters are relevant to Plaintiffs' claim that Bard failed to disclose relevant evidence to and misled the FDA. See Docs. 11011 at 4, 10323 at 2-3.
Plaintiffs seek exclusion of the FDA's 1996 reclassification memo because it does not directly relate to the 510(k) process or any Bard retrievable filter. Doc. 12095 at 3; see Doc. 12095-8. But as Defendants note, the memo explains why IVC filters are subject to 510(k) review instead of the premarket approval process, and tends to rebut Plaintiffs' argument that Bard strategically chose the easier path of clearance instead of approval. Doc. 12381 at 3 & n.3. Plaintiffs claim that the memo "sends the message that [the] FDA deemed Bard's devices safe and effective." Doc. 12095 at 4. But Plaintiffs have ample evidence to contest any such implication. See Doc. 10323 at 3. The Court cannot conclude that admission of the reclassification memo will unfairly prejudice Plaintiffs.
Similarly, the probative value of testimony from Bard witnesses that they regularly communicated and shared information with the FDA, and that they personally believe Bard filters are safe and effective, is not outweighed by the danger of unfair prejudice. Doc. 12095 at 4. Plaintiffs can make appropriate objections is they feel that gratuitous and irrelevant comments are being made during testimony.
Consistent with the Court's earlier ruling, Defendants will be precluded from presenting evidence or argument that the FDA "approved" Bard retrievable filters for market, or that clearance of the devices under 510(k) review constitutes a finding by the FDA that the filters are "safe and effective." Doc. 9881 at 6. But Defendants will not be precluded from presenting evidence of the FDA's 510(k) clearance process and lack of enforcement action against Bard. See id. at 3-6. The motion in limine (Doc. 12095) is denied.
Plaintiffs seek to exclude evidence and argument regarding a 2008 report issued by the U.S. Department of Health and Human Services titled "The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism" (the "Call to Action report"). Doc. 12097; see Doc. 12382-1. Plaintiffs contend that the report is irrelevant and confusing, and any probative value is substantially outweighed by the danger of unfair prejudice. Doc. 12097 at 1-3. Plaintiffs further contend that the report constitutes inadmissible hearsay. Id. at 3-4. Defendants argue that the report is admissible under the public records hearsay exception, is relevant, not prejudicial, and will not confuse the jury. Doc. 12382. The Court agrees with Defendants.
The Call to Action report is relevant to the design defect and negligence claims. With respect to the design defect claim, the jury must consider not only whether there was a reasonable alternative design for the Bard filter, but also whether Bard's failure to adopt that design rendered the filter "not reasonably safe." Wis. Stat. § 895.047(1)(a). The jury thus will be required to make a reasonableness determination with respect to the filter's safety. Similarly, in deciding Plaintiff's negligence claim, the jury will be required to decide whether Defendants acted reasonably in designing and releasing the filter. In making this determination, the jury may employ a risk-benefit analysis. See Meyer v. Val Lo Will Farms, Inc., 111 N.W.2d 500, 503 (Wis. 1961) (); Green v. Smith & Nephew AHP, Inc., 629 N.W.2d 727, 751 (Wis. 2001) (same); see also Restatement (Third) of Torts, § 2 cmt.d (1998) ( that "[s]ubsection (b) adopts a reasonableness ('risk-utility balancing') test as the standard for judging the defectiveness of product design").3
The Call to Action report is relevant to the risk-benefit analysis because it explains the benefits of IVC filters. It notes that deep vein thrombosis and pulmonary emboli are major public health problems, contributing to at least 100,000 deaths per year. Doc. 12382-1 at 8. The report calls for actions to reduce the risk of these diseases, and notes that IVC filters are one option for the prevention of pulmonary emboli. Id. at 26-28. The report plainly is probative of whether the benefits of Bard filters, when weighed against their risks, render Bard's actions unreasonable or the filter "not reasonably safe." See Doc. 10258 at 8 ().
The record does not support Plaintiffs' assertion that Defendants argued during the first two bellwether trials that "Bard acted at the direction of the Surgeon General" and "the Surgeon General considers Bard's IVC filters necessary" to treat pulmonary emboli. Doc. 12097 at 2. If Plaintiffs believe that Defendants are improperly implying the imprimatur of the Surgeon General, they may object at trial. See id. But the Court cannot conclude that admission of the Call to Action report will confuse the jury or unfairly prejudice Plaintiffs.
Nor can the Court conclude that the report constitutes inadmissible hearsay. The report falls within the public records hearsay exception. Fed. R. Evid. 803(8). Plaintiffs' citation of Philip Morris USA, Inc. v. Pollari, 228 So. 3d 115, 123 (Fla. Dist. Ct. App. 2017), does not help their position. Pollari found that Surgeon General reports satisfy Federal Rule of Evidence 803(8)(A)(iii) as records of factual findings from authorizedinvestigations, but excluded the reports because Florida law did not follow the federal rule. Id. Other cases have admitted Surgeon General reports under Rule 803(8). See Boerner v. Brown & Williamson Tobacco Co., 394 F.3d 594, 600 (8th Cir. 2005) (). The motion in limine (Doc. 12097) is denied.
Plaintiffs seek to exclude evidence and argument that Mrs. Hyde's falls in November 2012 and May 2013 caused or contributed to the Bard filter's failures. Doc. 12099. Defendants state that they will not argue or suggest that the falls contributed to the filter's failures or otherwise impacted Mrs. Hyde's filter-related complications. Doc....
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